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This study is based on a multicenter, phase III study in patients with systemic lupus erythematosus (SLE) in China to explore the long-term safety and efficacy of beliucumab in the treatment of SLE.
In the study, 359/424 (84.7%) of patients experienced ≥ 1 adverse event, most of which were mild or moderate, with the incidence decreasing over time.
In terms of efficacy, the SRI-4 response rate of the study cohort gradually increased, from 54.9% (190/346) at week 24 of year 1 to 80.5% (66/82) at week 48 of year 5.
Beliyuzumab is a whole-human monoclonal antibody that inhibits the proliferation and differentiation of B cells and induces autoreactive B cell apoptosis. And has been approved by the State Drug Administration (NMPA) for the treatment of systemic lupus erythematosus (SLE). Previously, double-blind, placebo-controlled trials have shown that belijuzumab can reduce disease activity and the occurrence of organ damage in patients with SLE, with good safety and tolerability. However, there are limited data on its long-term safety and efficacy in patients with SLE in China.
The open-label phase of the BLISS-NEA study was designed to evaluate the long-term safety and efficacy of belijuzumab in the treatment of patients with SLE in China. Professor Zhang Fengchun of Peking Union Medical College Hospital and his collaborators gave long-term safety and efficacy data on the treatment of SLE based on the phase III study of BLISSS-NEA. The findings were recently published in the journal RMD Open. (Impact Factor 5.117).
Research methodology
This Phase III open label study was conducted in patients with SLE in 24 centers in China. 424 patients received intravenous beliucumab 10 mg/kg per month and received standard therapy for ≤6 years (Figure 1).
Figure 1 BLISS-NEA study design
The primary endpoints were safety at week 24 and 48 of each study year, with secondary endpoints including SLE response index (SRI)-4 response rate, severe SLE recurrence, and prednisone use. The analysis was based on observational data from the use of the first dose of beliyultumab to the end of the study.
Research results
50.7% (215) of patients completed open-label studies, 49.1% (208) of patients withdrew from the study, and 1 patient died.
Security data
Overall, 359/424 (84.7%) of patients experienced ≥ 1 adverse event (AEs), most of which were mild or moderate, with incidence decreasing over time. The most common were upper respiratory tract infections (35.4%) and viral upper respiratory tract infections (13.9%). 96/424 (22.6%) of patients developed severe AEs; 26 (6.1%) discontinued study treatment/withdrawal from the study due to AEs.
Patients did not see severe allergic/hypersensitivity reactions, and the overall incidence of all infections of particular concern (limited to opportunistic infections, active tuberculosis, shingles, and sepsis) was 3.6 times per 100 patient-years. The systemic response rate after infusion is 1.5 times per 100 patient-years. The rate of shingles infection was 3.0 cases per 100 patient-years, of which 0.4 cases/100 patient-years were serious events.
During the study period, 1 case of papillary thyroid cancer and 1 case of vaginal cancer were reported in years 0-1 and 3-4, respectively, and no suicide deaths/suicide attempts were reported, nor were major depressive disorders reported.
Efficacy data
The SRI-4 response rate in the patient cohort in the study gradually increased, from 54.9% (190/346) at week 24 of year 1 to 80.5% at week 48 of year 5 (66/82, Figure 2).
Figure 2 Changes in SRI-4 response rates in the patient cohort
Severe relapse occurred in 13.9% (55/396) of patients. In 335 patients with a baseline prednisone dose > 7.5 mg/day (or equivalent), the dose was reduced to ≤ 7.5 mg/d over time: 9.0% (30/333) at week 24 of year 1 and 53.7% (36/67) at week 48 of year 5.
Conclusions of the study
Based on the data from this study, the researchers said that belijumab in the treatment of Chinese patients with SLE was well tolerated in the long-term follow-up of up to 6 years, and no new safety issues were seen, which is consistent with the results of previous long-term studies of beliucumab. These safety data, along with trends in the benefits of ongoing treatment in the study, support the benefits and risk profiles of beliyumab as a supplement to standard therapy for treatment of patients with active SLE in China.
参考文献：Zhang F, Zheng J, Li Y, Wang G, Wang M, Su Y, Gu J, Li X, Bass D, Chu M, Curtis P, DeRose K, Kurrasch R, Lowe J, Meizlik P, Roth DA. Phase 3, long-term, open-label extension period of safety and efficacy of belimumab in patients with systemic lupus erythematosus in China, for up to 6 years. RMD Open. 2022 Apr;8( 1):e001669. doi: 10.1136/rmdopen-2021-001669. PMID: 35428697.